Upload
others
View
11
Download
0
Embed Size (px)
Citation preview
Version 6.0
This document is a draft published for comments and suggestions
purposes. It is, therefore, subject to alteration and modification and may not
be referred to as SFDA’s document until approved by SFDA
Date of publication 15 July 2008
Date of implementation 5 July 2009
2
Regulatory Framework for
Drugs Approval
Version 6.0
Saudi Food & Drug Authority
Drug Sector
Please send your comments or suggestions before
January 17, 2020 to:
Please visit SFDA’s website at
http://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx
for the latest update
3
Saudi Food and Drug Authority
Vision and Mission
Vision
To be a leading international science-based regulator to protect and
promote public health
Mission
Protecting the community through regulations and effective controls to
ensure the safety of food, drugs, medical devices, cosmetics, pesticides
and feed
4
Document Control
Version Author Date Comments
1.0 Licensing department 15 March 2008 Initial draft for internal
consultation
2.0 Licensing department 15 July 2008 Published for comments
3.0 Licensing department 19 January 2009 Revised draft
4.0 Licensing department 5 July 2009 Final version posted
5.0 Regulatory Affairs 16 March 2014 Update
6.0 Executive Directorate
of Regulatory Affairs
17 December 2019 Update and published for comment
purposes
(Next page shows the updated
details)
5
What is the main updates in version no. 6?
Section Description of change
Glossary New definitions for New (innovative) and Generic products.
Add definitions for biotechnology products, blood products,
wave and medicinal gases
Update the definition of biologics
Add Stringent Regulatory Authorities (SRA) for veterinary
products
3. New Marketing
Authorization Application
Update the submission process
Responding period for the business validation inquiries is 30
working days
Add cases when the registration requests will be rejected
Total performance target for Herbal & health products reduced
from 155 to 95 working days
Update performance targets for veterinary products
4. Variation of Marketing
Authorization
Update the submission process
Responding period for the business validation inquiries is 30
working days
Add cases when the variation requests will be rejected
Total performance targets reduced as the following:
o Type 1A: from 60 to 30 working days
o Type 1B: from 120 to 60 working days
o Type 2: from 145 to 100 working days
5. Renewal of Marketing
Authorization
Update the submission process
Responding period for the business validation inquiries is 30
working days
Add cases when the renewal requests will be rejected
The renewal process is shorter and total performance target
reduced from 70 to 40 working days
Performance Targets The performance targets for all applications stated in details for all
steps:
Section 3.5: for Registration Request
Section 4.5: for Variation Request
Section 5.4: for Renewal Request
6
Table of Contents:
Acronyms and abbreviations .................................................................................... 8
Glossary ................................................................................................................... 9
1. Introduction .................................................................................................... 12
2. Scope: ............................................................................................................. 12
3. New marketing authorization application ....................................................... 13
3.1. Submission .................................................................................................. 13
3.1.1. Online submission ................................................................................... 13
3.1.2. Validation ................................................................................................ 13
3.1.2.1. Technical validation ................................................................................ 13
3.1.2.2. Business validation .................................................................................. 13
3.2. Assessment .................................................................................................. 14
3.2.1. Evaluation / inspection ............................................................................ 14
3.2.2. Testing ..................................................................................................... 15
3.3. Pricing ......................................................................................................... 16
3.4. Product licensing ......................................................................................... 16
3.5. Registration performance targets ................................................................ 18
3.5.1. Regular pathway ...................................................................................... 18
3.5.2. Priority review pathway .......................................................................... 19
3.5.3. Verification & abridged pathway ............................................................ 19
4. Variation of marketing authorization ............................................................. 20
4.1. Submission .................................................................................................. 20
4.1.1. Online submission ................................................................................... 20
4.1.2. Business validation .................................................................................. 21
4.2. Assessment .................................................................................................. 21
4.2.1. Evaluation / inspection ............................................................................ 21
4.3. Pricing ......................................................................................................... 22
4.4. Product licensing ......................................................................................... 22
4.5. Variation performance targets ..................................................................... 24
5. Renewal of marketing authorization ............................................................... 25
5.1. Submission .................................................................................................. 25
7
5.1.1. Online submission ................................................................................... 25
5.1.2. Business validation .................................................................................. 25
5.2. Pricing ......................................................................................................... 26
5.3. Product licensing ......................................................................................... 26
5.4. Renewal performance targets ...................................................................... 27
6. Appendix ........................................................................................................ 28
6.1. Application forms ....................................................................................... 28
8
Acronyms and Abbreviations
API Active Pharmaceutical Ingredients
ATC Anatomical Therapeutic Chemical Classification System
ATC vet Anatomical Therapeutic Chemical Classification System for veterinary
products
BSE Bovine spongiform encephalopathy
CEO Chief Executive Officer
COO Country of Origin
CPP Certificate of Pharmaceutical Product
CTD Common Technical Document
EMA European Medicines Agency
KSA Kingdom of Saudi Arabia
MA Marketing Authorization
MAA Marketing Authorization Application
MHRA Medicines and Healthcare products Regulatory Agency
NCE New Chemical Entity
NPC National Pharmacovigilance Center
RA Regulatory Affairs
SDR Saudi Drug Registration system
SFDA Saudi Food and Drug Authority
Swissmedic Swiss Agency for Therapeutic Products
TGA Therapeutic Goods Administration
TSE Transmissible Spongiform Encephalopathy
US FDA United States of America Food and Drug Administration
9
Glossary
Applicant The company or its representative
Biologicals
Medicinal products derived from a variety of natural
sources such as human or animal tissues, or microbiological
origins and produced by Culture & purification techniques.
They include a wide range of products such as vaccines,
blood and blood components, allergenics, somatic cells,
gene therapy, and tissues
Biosimilars
Therapeutic proteins produced by recombinant DNA
technology or gene expression method following the
footsteps of one licensed reference biotechnological
product after the expiration of the innovator’s patent. They
are complex and heterogeneous in their nature; hence they
are not considered generics, but as closely similar to the
innovator’s drug as possible
Biotechnology
products
Medicinal products produced by biotechnology methods
and other cutting-edge technologies. They include a wide
range of products such as recombinant Blood products,
recombinant vaccines, and Biosimilars
Blood products
They are a wide range of medicinal product sourced from
human blood or plasma (source material) that can be
collected and tested at “Blood Establishments” and
obtained by industrial process “Fractionation” of human
plasma of a large number of donations (up to tens of
thousands) that are pooled together
Validation (Business
& technical)
The process of checking if documents satisfy a certain
criterion
Common Technical
Document (CTD)
An international harmonized format for submissions for
approval of pharmaceuticals. The CTD provides a
standardization of the presentation of the content
Dosage form
The finished formulation of a pharmaceutical product, e.g.
tablet, capsule, suspension, solution for injection,
suppository
Drug
An article intended for use in the diagnosis, cure mitigation,
treatment, or prevention of disease and which is intended to
affect the structure or function of the body
10
Drug Application A drug application includes the application form, the
product file and the drug samples
Generic
(multisource)
product
A product created to be equivalent to the innovative / brand
name product in dosage form, strength, route of
administration, quality, performance characteristics and
therapeutic indication(s)
Note:
Drug application will be considered as Generic irrespective
of whether the innovative product registered or not at
SFDA
Hard copy - product
file
The paper-based submission of selected documents of the
product file
Health product Refer to the SFDA classification guidance
Herbal product
Any finished labeled medicinal products that contain as
active ingredients aerial or underground parts of plants or
other plant materials or the combination of them, whether
in crude state or plant preparation that is used to treat or
prevent diseases or ailments or to promote health and
healing. Plant materials include juices, gums, fatty oils and
any other substance of this nature
New (innovative)
product
A product that includes new chemical entity and launched
in the market by the innovator company
Inquiry A questions or clarifications posted in SDR system to be
responded by the applicant
Medicinal gas Any gas or mixture of gases classified as a medicinal
product
Radiopharmaceutical
product
A radioactive drug that can be administered safely to
humans for diagnostic and therapeutic purposes.
Reference number /
sub-product number
Any combination of letters and numbers that is assigned to
the transaction in order to follow it.
Renewal of
marketing
authorization
A process of renewing the marketing authorization license
every five years.
SADAD A system that links between the commercial sector and the
local banks; it offers the ability to collect its customer
11
payment electronically through all the banking channels in
KSA around the clock.
SFDA's pricing rules
The pricing guideline “The Rules for Pharmaceutical
Products Pricing” which include the general requirements
and criteria for pricing a pharmaceutical product and
constitute the general framework of the “Pharmaceutical
Products Pricing Committee” to suggest the price.
Product file The electronic version of the product file presented in CDs
or DVDs.
Stringent Regulatory
Authority (SRA)
For human products: USFDA, EMA, MHRA,
Swissmedic, Health Canada and TGA.
For veterinary products: European Medicine Agency
(Europe), Veterinary Medicines Directorate (UK), Health
Canada Drug Product Database (Canada), Australian
Pesticides and Veterinary Medicines Authority (Australia),
Food and Drug Administration (USA), The French Agency
for Veterinary Medicinal Products (France), Health Product
Regulatory Authority (Ireland), Federal Office of
Consumer protection and Food Safety & Paul Ehrlich
Institute (Germany), New Zealand Food Safety (New
Zealand), Federal Agency for Medicines and Health
Products (Belgium), The Netherlands Veterinary
Medicines Institute (Netherlands) and Spanish Agency of
Medicines and Medical Devices (Spain).
Vaccines
Preparations that contain antigenic substances capable of
inducing a specific and active immunity against the
infecting agent or the toxin or the antigen produced by it.
Variation A process of informing SFDA of any minor or major
changes in the drug product.
Veterinary product
Any substance or combination of substances presented as
having properties for treating or preventing disease in
animals; or any substance or combination of substances that
may be used in, or administered to, animals with a view
either to restoring, correcting or modifying physiological
functions by exerting a pharmacological, immunological or
metabolic action, or to making a medical diagnosis.
Wave Set of inquiries from one or multiple departments sent to
applicants during assessment process.
12
1. INTRODUCTION
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed this
administrative document to provide assistance for stakeholders on how to submit
applications for various types of drug products and the procedure to authorize the
applications.
Besides the Market Authorization Application (MAA) of various types of drug
products, it also describes variations applications and renewal of MAA. Various
application forms and time-frame for processing applications to marketing the
product in Saudi Arabia are also included in this document.
2. Scope:
This framework applicable to all types of drug product submitted for registration,
variation or renewal.
13
3. NEW MARKETING AUTHORIZATION APPLICATION
(MAA) 1
The MAA of pharmaceutical product will be subjected to the followings processes:
3.1. Submission
The process of submitting a New MAA consists of two steps:
3.1.1. Online submission
1. The applicant shall apply through SDR system to fill the application
form and pay the fees
2. Upload the product file; The components of the file shall follow the
requirements and guidelines published on SFDA website
3.1.2. Validation
The product file will be validated in technical and business bases to
ensure the applicant fulfills the requirement. The validation involves two
steps:
3.1.2.1. Technical validation
The SDR system will validate the submission automatically after the
company upload the file on the SDR portal. The validation’s result will
be sent by email through SDR system to the applicant.
3.1.2.2. Business validation
1. The product file will be validated to ensure that all information
provided is according to the requirements and guidelines.
2. If any information is missing or incorrect, an electronic inquiry
will be forwarded to the applicant through the SDR system. The
applicant will be given an opportunity to complete the file within
30 working days.
1 Performance targets for every step provided at the end of this part (section 3.5) for all pathways
(Regular, priority, verification and abridged)
14
3. The completed file will proceed to the next steps for Assessment
(section 3.2)
The registration request will be rejected in the following cases:
No response from the applicant within 30 working days.
Failure to provide acceptable clarifications after the 4th wave.
Figure 1 Schematic chart of the submission process (section 3.1)
3.2. Assessment
The MAA for different drug submission types subject to the following
processes:
3.2.1. Evaluation / Inspection
1. The RA will distribute the registration request to the relevant related
departments to assess quality, safety and efficacy.
For Inspection: the department will check the approval of
manufacturing line; if not approved:
15
o Visit will be scheduled for inspection depending on
the time available for both inspectors and the
company.
o After the visit, the inspection report will be sent to the
company (please, refer to the guidance of Good
Manufacturing Practice for Medicinal product).
2. If more information or clarification is required, an electronic inquiry will
be posted through SDR system as one wave for evaluation and
inspection. A response should be received within 90 working days.
3. Once the evaluation and inspection are completed, the registration
request will be forwarded to Pricing (section 3.3)
The registration request will be rejected in the following cases:
No response from the applicant within 90 working days.
Failure to provide acceptable clarifications after the 4th wave.
3.2.2. Testing:
1. The registration request will be forwarded to the SFDA Central
Laboratories.
2. If more information or clarification is required, an electronic inquiry
will be posted through SDR system
3. Samples and working standards shall be delivered by the applicant to
SFDA Central Laboratories.
Notes:
Testing will not delay the registration of a product.
The first batch will not be released if the company did not submit the
requirements and inquiries that requested by SFDA Central
Laboratories during product registration period.
16
3.3. Pricing
1. The Pricing Department will review product’s price according to the
“SFDA's pricing rules”.
2. If more information or clarification is required, an electronic inquiry will
be posted through SDR system. A response should be received within 90
working days.
3. The product’s price will be forwarded to Registration Committee
(section 3.4).
The registration request will be rejected in the following cases:
No response from the applicant within 90 working days.
Failure to provide acceptable clarifications after the 4th wave.
3.4. Product licensing
1. The Registration Committee will review the registration request for
approval, rejection or ask for further information (if needed).
2. The SFDA CEO will approve the meeting minutes.
3. For approved registration request, the applicant will be notified through
SDR system to issue the MA. Otherwise, submit an appeal.
Appeal Process:
The applicant has the right to appeal against any decision within 60 calendar days,
for more information refer to Guidance for Submission.
17
Figure 2 schematic figure showing the different levels for getting a marketing authorization
(section 3.2, 3.3 and 3.4)
18
3.5. Registration performance targets
The performance target in any step will STOP if a clarification or
information is needed from the applicant, and resume after receiving the
response.
All days are considered as working days.
Total Performance Target calculated without the Business Validation for
all pathways
2 For Evaluation 3 For inspection
3.5.1. Regular pathway:
Registration
phases
Technical
Validation
Business
Validation
Evaluation /
Inspection
Testing Pricing Product
licensing
Total
Performance
Target section
3.1.2.1
section
3.1.2.2
section
3.2.1
section
3.2.2
section
3.3
section
3.4
No. of Waves - 4 4 - 4 -
Human Generic - 10 120 - 20 15 155
Human New Drugs
registered in SRA
- 10 245 - 20 15 280
Human New Drugs not
registered in SRA
- 10
370
- 20
15
405
Human Biologics
registered in SRA
- 10
245
- 20
15
280
Human Biologics not
registered in SRA
- 10
370
- 20
15
405
Radiopharmaceuticals - 10
245
- 20
15
280
Veterinary Generics - 10
150
- - 15
165
Veterinary New Drugs
registered in SRA
- 10
245
- - 15
260
Veterinary New Drugs
not registered in SRA
- 10
370
- - 15
385
Veterinary Biologics
registered in SRA
- 10
245
- - 15
260
Veterinary Biologics not
registered in SRA
- 10
370
- - 15
385
Herbal & health
products
- 10
602
303
- 20
15
95
19
3.5.2. Priority review pathway (40% reduction)4:
3.5.3. Verification & abridged pathway5:
4 Refer to the Guidance for Priority Review of Product Registration 5 Refer to the Registration According to Verification and Abridged
Registration
phases
Technical
Validation
Business
Validation
Evaluation
/
Inspection
Testing Pricing Product
licensing
Total
Performance
target
section
3.1.2.1
section
3.1.2.2
section
3.2.1
section
3.2.2
section 3.3 section
3.4
No. of Waves - 4 4 - 4 -
Human Generic - 10 72 - 12 9 93
Human New Drugs
registered in SRA
- 10
147 - 12 9 168
Human New Drugs
not registered in SRA
- 10
222
- 12 9 243
Human Biologics
registered in SRA
- 10
147 - 12 9 168
Human Biologics not
registered in SRA
- 10
222 - 12 9 243
Radiopharmaceuticals - 10 147 - 12 9 168
Registration
phases
Technical
validation
Business
validation
Evaluation /
Inspection
Testing Pricing Product
licensing
Total
Performance
target
section
3.1.2.1
section
3.1.2.2
section
3.2.1
section
3.2.2
section
3.3
section
3.4
No. of Waves - 4 4 - 4 -
Verification - 5 15 - 5 10 30
Abridged - 5 40 - 10 10 60
20
4. VARIATION OF MARKETING AUTHORIZATION6
Any changes on a registered product has to be submitted to the SFDA as a Variation
of MAA. The variations are classified into two main categories:
A. Minor changes
Type IA: minor variations that does not require prior approval before
implementation (“Do and Tell” procedure) but require notification
submitted by MAH within 60 working days after implementation.
Type IB: minor variations that must be submitted to the SFDA by MAH
before implementation, but do not require a formal approval. However,
the MAH must wait a period of 60 working days to ensure that the
application is deemed acceptable by the SFDA before implementing the
change (“Tell, Wait and Do” procedure).
B. Major variation
Type II: major variations in which there might be a significant impact
on the Quality, Safety or Efficacy of a pharmaceutical product and
require prior approval before implementation.
The variation request subjects to the following process:
4.1. Submission
The process of submitting a variation of MAA consists of two steps:
4.1.1. Online submission
1. The applicant shall apply through SDR system to fill the application
form and pay the fees.
2. Upload the product file; The components of the file shall follow the
requirements and guidelines published on SFDA website
For applications made via the new SDR system, three parallel variation
applications can be submitted at a time, each includes administrative, quality
or safety variations. Each category of variations will be assigned to the
related departments.
6 Performance targets for each step provided at the end of this part (section 4.5)
21
4.1.2. Business Validation
1. The product file will be validated to ensure that all information
provided is according to the requirements and/or guidelines.
2. If any information is missing or incorrect, an electronic inquiry
will be forwarded to the applicant through the SDR system. The
applicant will be given an opportunity to complete the file within
30 working days.
3. The completed file will proceed to the next step for Assessment
(section 4.2).
The variation request will be rejected in the following cases:
No response from the applicant within 30 working days.
Failure to provide acceptable clarifications after the first wave.
4.2. Assessment
Depending on the type of variation, one or more department may review the
variation application.
4.2.1. Evaluation / Inspection:
1. The variation request will be distributed to the relevant related
department – as needed;
For the inspection related requests: the department will check
the approval of manufacturing line, If not approved:
o Visit will be scheduled for inspection depending on
the time available for both inspectors and the
company.
o After the visit, the inspection report will be sent to the
company (please, refer to the guidance of Good
Manufacturing Practice for Medicinal product).
2. If more information or clarification is required, an electronic inquiry will
be posted through SDR system. The response should be received within
90 working days.
22
3. Reports (recommendation for approval or rejection) will be collected by
the RA.
4. The reports will be forwarded (if needed) to pricing (section 4.3) and
registration committee (section 4.4) depending on the type of variation.
The variation request will be rejected in the following cases:
No response from the applicant within 90 working days.
Failure to provide acceptable clarifications after the first wave.
4.3. Pricing
1. The Pricing Department handles all variation requests that require
pricing review according to “SFDA’s pricing rules”.
2. If more information or clarification is required, an electronic Inquiry will
be posted through SDR system. A response should be received within 90
working days.
3. The approved price will be forwarded to the Registration Committee
(section 4.4).
The variation request will be rejected in the following cases:
No response from the applicant within 90 working days.
Failure to provide acceptable clarifications after the first wave.
4.4. Product Licensing
For all variation types except variation affecting product price:
1. The RA will approve the final report.
2. Notify the applicant through SDR system.
For variation affecting product price:
1. The Registration Committee will review the variation request for
approval, rejection or ask for further information (if needed).
23
2. The SFDA CEO will approve the meeting minutes.
3. For approved variation request, the applicant will be notified
through SDR system. Otherwise, submit an appeal.
General variation notes:
For applications made via the new SDR system; after the completion of an
application of a particular category (by approval or rejection), another
application of the same category can be submitted.
For application includes more than one type of variation, the maximum total
performance target will be considered. For example: application includes
type 1B and type II, the total performance target for the application is 100
working days.
Appeal Process:
The applicant has the right to appeal within 60 calendar days of the SFDA’s final
decision, for more information refer to Guidance for submission.
Figure 3 Schematic figure showing the workflow of Variation
24
4.5. Variation performance targets:
The performance target in any step will STOP if a clarification or
information is needed from the applicant, and resume after receiving the
response.
All days below are considered as working days.
Total Performance Target calculated without the Business Validation for
all types of variations.
Phases
Business
Validation
Assessment Pricing Product
licensing
Total Performance
target section 4.1.2 section 4.2 section 4.3 section 4.4
No. of Waves 1 1 1 -
Type IA 5 20 - 10 30
Type IB 5 40 10 10 60
Type II 5 80 10 10 100
5. RENEWAL OF MARKETING AUTHORIZATION7
An applicant shall submit a renewal request every five years. It is possible to request for
renewal within six months of the certificate expiry.
As most of the registered drugs have went through at least one renewal process or have
been registered through SDR system; therefore, the renewal process is shorter as follows:
5.1. Submission
The process of submitting a renewal of MA consists of two steps:
5.1.1. Online submission:
1. The applicant shall apply through SDR system to fill the application
form and pay the fees.
2. Upload the renewal file; The components of the file shall follow the
requirements and guidelines published on SFDA website.
5.1.2. Business Validation:
1. The product file will be validated to ensure that all information
provided are according to the requirements and/or guidelines.
2. If any information is missing or incorrect, an electronic Inquiry will
be forwarded to the applicant through SDR system. The applicant will
be given an opportunity to complete the file within 30 working days.
3. The completed file will proceed to the Pricing Department (section
5.2).
The renewal request will be rejected in the following cases:
No response from the applicant within 30 working days.
Failure to provide acceptable clarifications after the first wave.
7 Performance targets for each step provided at the end of this part (section 5.4)
26
5.2. Pricing
1. The Pricing Department will review the price according to the “SFDA's
pricing rules”.
2. If more information or clarification is required, an electronic inquiry will be
posted through SDR system. A response should be received within 30
working days.
3. The approved price will be forwarded to the product licensing (section 5.3).
The renewal request will be rejected in the following cases:
No response from the applicant within 30 working days.
Failure to provide acceptable clarifications after the first wave.
5.3. Product Licensing
1. The RA will issue the renewal of MA.
2. The applicant will be notified through SDR system. Otherwise, submit an
appeal.
Note: The rejected renewal applications obligate the applicant to submit a new one.
Figure 4 Schematic figure showing the renewal process of a marketing authorization
27
5.4. Renewal performance targets:
The performance target in any step will STOP if a clarification or information
is needed from the applicant, and resume after receiving the response.
All days below are considered as working days.
Total Performance Target calculated without the Business Validation.
Phases of Renewal No. of Waves Total Performance target
Business validation
(section 5.1.2)
1 5
Pricing
(section 5.2)
1 30
Product licensing
(section 5.3)
- 10
Total performance target: 40
28
6. APPENDIX
6.1. Application Forms
Application form Page
Marketing Authorization Application of Pharmaceutical Product 30
Application for Variation to a Marketing Authorization 61
Note:
The application forms are available electronically in SDR system. These forms
are only for viewing and preparing the required information before starting the
process of submission.
29
تسويق مستحضر دوائيطلب رخصة
Marketing Authorization Application for Pharmaceutical Product
30
1 Type of Application
The following sections should be completed where appropriate.
This application concerns:
Human medicinal product
Herbal product
Veterinary product
1.1 Please choose the type of product:
Human medicinal product
New Drug (1.2.1.1)
Biological Drug (1.2.1.2)
Radiopharmaceutical Drug (1.2.1.3)
Generic (Multisource) Drug (1.2.1.4)
Health product (1.2.1.5)
Veterinary product
New Drug (1.2.3.1)
Biological Drug (1.2.3.2)
Generic (Multisource) Drug (1.2.3.3)
Health product (1.2.3.4)
Herbal product (1.2.3.5)
1.2 Please provide the following information for the product:
1.2.1 Human medicinal product
1.2.1.1 New Drug Application
New Chemical Entity (NCE)
Known active substance
31
1.2.1.1.1 Is Saudi Arabia the country of origin (COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Certifying Authority:
o Date of authorization (dd/mm/yyyy):
o Country:
1.2.1.1.2 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
No
1.2.1.1.3 Is this product registered in SRA?
Yes, please specify the SRA:
32
No
1.2.1.1.4 Is this product under-license?
Yes, please specify the MAH:
No
1.2.1.1.5 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.1.1.6 This product is candidate for:
Abridge registration process
Verification registration process
Priority review process, please specify the SFDA letter number:
None of the above
1.2.1.2 Biological Drug Application
Biological
Biosimilar
Blood product
Vaccine
Others, please specify:
1.2.1.2.1 Is Saudi Arabia the country of origin (COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
Dosage form:
Marketing authorization holder:
33
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
Certifying Authority:
Date of authorization (dd/mm/yyyy):
Country:
1.2.1.2.2 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
No
1.2.1.2.3 Is this product registered in SRA?
Yes, please specify the SRA:
No
1.2.1.2.4 Is this product under-license?
Yes, please specify the MAH:
No
1.2.1.2.5 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.1.2.6 This product is candidate for:
Abridge registration process
34
Verification registration process
Priority review process, please specify the SFDA letter number:
None of the above
1.2.1.3 Radiopharmaceutical Drug Application
1.2.1.3.1 Is Saudi Arabia the country of origin(COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
Dosage form:
Marketing authorization holder information in COO:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.1.3.2 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
35
No
1.2.1.3.3 Is this product registered in SRA?
Yes, please specify the SRA:
No
1.2.1.3.4 Is this product under-license?
Yes, please specify the MAH:
No
1.2.1.3.5 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.1.3.6 This product is candidate for:
Abridge registration process
Verification registration process
Priority review process, please specify the SFDA letter number:
None of the above
1.2.1.4 Generic (Multisource) Drug Application
1.2.1.4.1 Is Saudi Arabia the country of origin (COO)?
Yes (complete part 1.2.1.4.2)
No (complete the following information):
Product information:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
36
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.1.4.2 Reference Product Information:
Trade name:
Product strength/unit:
Dosage form:
1.2.1.4.3 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
No
1.2.1.4.4 Is the product a 1st or 2nd Generic?
Yes, please choose:
1st Generic
2nd Generic
No
1.2.1.4.5 Is this product a 2nd Brand?
Yes, please choose the Innovator product from the list:
No
1.2.1.4.6 Is this product under-license?
Yes, please specify the MAH:
37
No
1.2.1.4.7 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.1.4.8 Is this product candidate for Priority Review process?
Yes, please specify the SFDA letter number:
No
1.2.1.5 Health product Application
1.2.1.5.1 Is Saudi Arabia the country of origin (COO)?
Yes (complete section 2)
No (complete the following information)
Product information:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
38
1.2.1.5.2 Is this product under-license?
Yes, please specify the MAH:
No
1.2.2 Herbal product
Is Saudi Arabia the country of origin(COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
Dosage form:
Marketing authorization holder information in COO:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.2.1.1 Is this product under-license?
Yes, please specify the MAH:
No
39
1.2.3 Veterinary product
1.2.3.1 New Drug Application
New Chemical Entity (NCE)
Known active substance
1.2.3.1.1 Is Saudi Arabia the country of origin (COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Certifying Authority:
o Date of authorization (dd/mm/yyyy):
o Country:
1.2.3.1.2 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
40
No
1.2.3.1.3 Is this product registered in SRA?
Yes, please specify the SRA:
No
1.2.3.1.4 Is this product under-license?
Yes, please specify the MAH:
No
1.2.3.1.5 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.3.1.6 This product is candidate for:
Abridge registration process
Verification registration process
Priority review process, please specify the SFDA letter number:
None of the above
1.2.3.2 Biological Drug Application
Biological
Biosimilar
Blood product
Vaccine
Others (please specify):
Is Saudi Arabia the country of origin (COO)?
Yes (go to section 2)
No (complete the following information)
Product information in COO:
Trade name:
Product strength/unit:
41
Dosage form:
Marketing authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
Certifying Authority:
Date of authorization (dd/mm/yyyy):
Country:
1.2.3.2.1 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
No
1.2.3.2.2 Is this product registered in SRA?
Yes, please specify the SRA:
No
1.2.3.2.3 Is this product under-license?
Yes, please specify the MAH:
No
1.2.3.2.4 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
42
1.2.3.2.5 This product is candidate for:
Abridge registration process
Verification registration process
Priority review process, please specify the SFDA letter number:
None of the above
1.2.3.3 Generic (Multisource) Drug Application
1.2.3.3.1 Is Saudi Arabia the country of origin (COO)?
Yes (complete part 1.3.3.3.2)
No (complete the following information)
Product information:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.3.3.2 Reference Product Information:
Trade name:
43
Product strength/unit:
Dosage form:
1.2.3.3.3 Is the product registered in GCC?
Yes, please specify the following
o Registration number:
o Trade name:
o Committee meeting number:
No
1.2.3.3.4 Is the product a 1st or 2nd Generic?
Yes, please choose:
1st Generic
2nd Generic
No
1.2.3.3.5 Is this product a 2nd Brand?
Yes, please choose the Innovator product from the list:
No
1.2.3.3.6 Is this product under-license?
Yes, please specify the MAH:
No
1.2.3.3.7 Is this product from the SFDA exemption list?
Yes, please choose the product:
No
1.2.3.3.8 Is this product candidate for Priority Review process?
Yes, please specify the SFDA letter number:
No
1.2.3.4 Health product Application
Is Saudi Arabia the country of origin (COO)?
44
Yes (complete section 2)
No (complete the following information)
Product information:
Trade name:
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.3.4.1 Is this product under-license?
Yes, please specify the MAH:
No
1.2.3.5 Herbal product Application
Is Saudi Arabia the country of origin (COO)?
Yes (complete section 2)
No (complete the following information)
Product information:
Trade name:
45
Product strength/unit:
Dosage form:
Marketing Authorization holder:
o Name:
o Address :
Line 1:
Line 2:
Line 3:
Postal/Zip code:
City:
Country:
o Date of authorization (dd/mm/yyyy):
o Certifying Authority:
o Country:
1.2.3.5.1 Is this product under-license?
Yes, please specify the MAH:
No
46
2 Product Information Details
The following sections should be completed where appropriate.
2.1 Product information:
2.1.1 Proposed trade name in English:
2.1.2 Proposed trade name in Arabic:
2.1.3 Product number 1:
2.1.3.1 List the active substance(s):
Single active substance
Multiple active substances
Name of
active
substance(s)
Operator8 Quantity Unit
Reference/
Monograph
standard
2.1.3.2 List the excipient(s):
Name of
excipient(s) Operator1 Quantity Unit
Reference/
Monograph
standard
2.1.3.3 Pharmaco-therapeutic group: (Please use current ATC code)
ATC Code Group
No ATC code has been assigned
2.1.3.4 Raw plant materials: (for Herbal products only)
8 Quantity operator: equal to, less than, more than, less than or equal to, more than or equal to, equivalent to, approximately equal to, range
47
2.1.3.5 Scientific name, family: (for Herbal products only)
2.1.3.6 Traditional or common name (Arabic and/or English): (for Herbal
products only)
2.1.3.7 Used parts: (for Herbal products only)
2.1.3.8 Dosage form:
2.1.3.9 Strength
2.1.3.10 Unit of strength:
2.1.3.11 Package size: 1 value only
Package size Volume Unit of Volume
2.1.3.12 Route of administration:
2.1.3.13 Administration device (if applicable):
2.1.3.14 Primary packaging:
2.1.3.15 Secondary packaging:
2.1.3.16 Is a GTIN assigned for this pack?
Yes, please specify the value:
No
2.1.3.17 Proposed shelf life:
2.1.3.18 Proposed shelf life after first opening (if applicable):
2.1.3.19 Proposed shelf life after reconstitution or dilution (if applicable):
2.1.3.20 Proposed storage conditions:
2.1.3.21 Proposed storage conditions after first opening (if applicable):
2.1.3.22 Reference Pharmacopoeia:
2.1.3.23 Do you have a Certificate of a Pharmaceutical Product (CPP)?
Yes
No
48
If not, do you have a marketing authorization (or free sales) certificate
from the country of origin (COO)?
Yes
No
2.1.3.24 List and specify any material of animal source contained in any
component of the product, if applicable:
Material Animal Animal part Free from BSE/TSE
Please note that any pork content has to be clearly specified.
It should be noted that all material used must be free from BSE/TSE. If a certificate confirming that the product is free from BSE/TSE is available, it should be provided.
2.1.3.25 Maximum Residual Limit (MRL) Status: (only for food producing
species)
Substance(s) Species Target tissue(s) MRL Remarks
2.1.3.26 Withdrawal Period:
2.1.3.27 Withdrawal Period Unit:
49
3 Manufacturers Details:
The following sections should be completed where appropriate.
3.1 Active Pharmaceutical Ingredient (API) manufacturers:
Name of manufacturer
Name of ingredient
Address9 Phone Fax Activity
10
Is it GMP certified?
Yes No
Certifying Authority
Date of certification
(dd/mm/yyyy)
3.2 Excipients manufacturers:
Name of
manufacturer
Name of
excipient Address3 Phone Fax Activity3
Is it GMP
certified?
Yes No
Certifying
Authority
Date of
certification
(dd/mm/yyyy)
3.3 Finished Product manufacturers:
Name of manufacturer
Address3 Phone Fax Activity3 Is it GMP certified?
Yes No
Certifying Authority
Date of certification
(dd/mm/yyyy)
9 Full address as Line 1, 2 & 3; Postal/Zip code, City & Country 10 A drop-down menu
50
4 Marketing Authorization Details
The following sections should be completed where appropriate.
4.1 Marketing authorization holder legally responsible for placing the
product on the market in KSA11:
Company Name:
Address:
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
Phone:
Fax:
E-Mail:
4.2 Person authorized for communication in KSA on behalf of the
applicant:
Person Name:
o First name:
o Middle name:
o Family/last name:
Company Name12:
Address:
11 A drop-down menu (transferred from DENR or Re-engineered system after normalization) 12 A drop-down menu (transferred from DENR or Re-engineered system after normalization)
51
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
Phone:
Fax:
E-Mail:
4.3 Person/Company authorized for communication between the
marketing authorization holder and the SFDA after authorization, if
different from 3.2 in KSA:
Person Name:
o First name:
o Middle name:
o Family/last name:
Company Name13:
Address:
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
Phone:
13 A drop-down menu (transferred from DENR or Re-engineered system after normalization)
52
Fax:
E-Mail:
4.4 Person qualified for Pharmacovigilance in KSA:
Name:
o First name:
o Middle name:
o Family/last name:
Address:
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
Phone:
Fax:
E-Mail:
53
5 Scientific Advice
5.1 Was there any formal scientific advice given by the SFDA for this
medicinal product?
Yes, please complete the following:
Date (dd/mm/yyyy):
Reference number of the scientific advice letter:
No
54
6 Pediatric Development Program
6.1 Is there a pediatric development program for this medicinal product?
Yes, please indicate the relevant section(s) in the dossier:
No
55
7 Legal Status of the Product
The following sections should be completed where appropriate.
7.1 Proposed dispensing classification:
Subject to medical prescription:
By a licensed doctor in the KSA:
Consultant
Senior Assistant
Assistant
GP
Restricted prescription
Special distribution program
Hospital-only item
Not subject to medical prescription:
By a licensed Pharmacist – Behind the counter (BTC)
Over the counter (OTC)
56
8 Status of the application in other regulatory agencies
Tick the appropriate box and fill the information.
Authorized
List all countries where the product is authorized for marketing:
Country Trade name
Product strength/unit
Dosage form
Marketing authorization
holder
Date of authorization (dd/mm/yyyy)
Pending
List all countries where the product application is pending:
Country Trade name
Product strength/unit
Dosage form
Date of submission
(dd/mm/yyyy)
Refused
List all countries where the product has been refused for marketing:
Country Trade name
Product strength/unit
Dosage form
Reason for refusal
Date of refusal (dd/mm/yyyy)
Withdrawn (by applicant after authorization)
List all countries where the product has been withdrawn after authorization:
Country Trade name
Product strength/unit
Dosage form
Date of withdrawal
(dd/mm/yyyy)
Reason for withdrawal
Suspended/revoked (by competent authority)
List all countries where the product has been suspended or revoked:
Country Trade name
Product strength/unit
Dosage form
Date of suspension/rev
Reason for suspension/ revocation:
57
ocation (dd/mm/yyyy)
9 Price Certificate Form
The following sections should be completed where appropriate.
9.1 Ex-Factory Price:
9.1.1 Country of Origin’s currency
9.2 Wholesale Price
9.2.1 Country of Origin’s currency
9.3 Public price
9.3.1 Country of Origin’s currency
9.4 Proposed CIF to KSA
9.4.1 Currency
9.5 The other price in countries where the product is marketed:
No
Countr
y
Nam
e
Pack S
ize
Ex-
Facto
ry
Price
Curr
ency
CIF
Price
Curr
ency
Pub
lic
price
Curr
ency
note
s
1 Algeria
2 Australia
3 Argentina
4 Bahrain
5 Belgium
6 Canada
7 Cyprus
8 Denmark
9 Egypt
10 France
58
No
Countr
y
Nam
e
Pack S
ize
Ex-
Facto
ry
Price
Curr
ency
CIF
Price
Curr
ency
Pub
lic
price
Curr
ency
note
s
11 Germany
12 Greece
13 Holland
14 Hungary
15 Ireland
16 Italy
17 Jordan
18 Kuwait
19 New Zealand
20 Oman
21 Portugal
22 Lebanon
23 Japan
24 South Korea
25 Spain
26 Sweden
27 Switzerland
28 Turkey
29 UAE
30 UK
31 Others
59
Declaration:
I hereby certify that the submitted information is true and accurate and changes
will not be made until they are approved by SFDA.
Title:
Name:
Signature:
Date:
Company stamp:
60
ة التسويق طلب تعديل رخص
Application for Variation to a Marketing Authorization
61
1 Request type
1.1 This application concerns:
Administrative Changes
Quality Changes
Safety, Efficacy, or Pharmacovigilance Changes
62
2 Type(s) of variation(s):
2.1 Variations included in this application:
Number and title of
variation, as per the
guideline14
Procedure Type Date of
Implementation
2.2 Precise scope and background for change (Include a description
and background of all the proposed changes with its proposed
Classification)
Current Proposed
2.3 Does this change affect the last updated drug application form?
Yes, which part? Please specify to the lowest level and state the new
value:
Section 2 - Product Information Details: Please choose the
field(s) and type the new value
Section 3 - Manufacturers Details: Please choose the field(s)
and type the new value
Section 4 - Marketing Authorization Details: Please choose the
field(s) and type the new value
14 Choose from the drop-down menu of all variations in the GCC variation guideline
63
Section 7 - Legal Status of the Product: Please choose the
field(s) and type the new value
Section 9 - Price Certificate Form: Please choose the field(s)
and type the new value
No
Declaration:
I hereby certify that the submitted information is true and accurate and changes
will not be made until they are approved by SFDA.
Title:
Name:
Signature:
Date:
Company stamp:
64